Wockhardt Limited Product: pharmaceutical manufacturing facilities Date:11/25/2013 Investigators from the U.S. Food and Drug Administration (FDA) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of Section 501(a)(2)(B) of...Read More
Company: Hospira Inc Date of Enforcement Report: 11/25/2013 Class l: PRODUCT Hospira GemStar Infusion System Models 13000, 13100, 13150, 13086, 13087, 13088 The GemStar Infusion System is a small, lightweight, single-channeled device designed for use in the home, hospital or anywhere electronic infusion is required. The device is intended for use in intravenous, arterial, subcutaneous,...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.